BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEPTUNE CONCHA THERM HEATER

    MDR report key: 1479223 · Received June 30, 2009

    Report

    Report Number
    3003898360-2009-00137
    Event Type
    Death
    Date Received
    June 30, 2009
    Date of Event
    March 4, 2009
    Report Date
    June 18, 2009
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    BZE
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE RECEIVED FOR INVESTIGATION. EVAL: MANUFACTURING PROCESSES WERE REVIEWED. DHR REVIEW SHOWED NO ISSUES WITH THIS LOT # CONCERNING THIS COMPLAINT. RESULT: NO CHANGES IN THE MATERIAL, MACHINE, MANPOWER, METHOD OR MEASUREMENT WERE MADE. CONCLUSIONS: THE ROOT CAUSE COULD NOT BE IDENTIFIED FOR THE DESCRIBED COMPLAINT, HOWEVER, THIS FAILURE MODE HAS BEEN ADDED TO THE TRENDING ANALYSIS. QA AND MANUFACTURING PERSONNEL WERE MADE AWARE OF THE POSSIBILITY OF THIS DEFECT ACCORDING TO THE CUSTOMER COMPLAINT. NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. IF SAMPLE BECOMES AVAILABLE, INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    INCIDENT REPORTED AS MEDWATCH, RECEIVED ON 06/18/2009 FROM FDA AND ALSO INFO OBTAINED FROM HOSPITAL. PT EXTUBATED HERSELF AND WAS FOUND UNRESPONSIVE AND COULD NOT BE REVIVED. THE NEBULIZER WAS IN USE AND APPEARED TO BE FUNCTIONING. THE ONLY FURTHER INFO OBTAINED REVEALED PT HAD A HISTORY OF SIGNIFICANT HEART FAILURE, RESPIRATORY FAILURE, DIABETES, CHRONIC RENAL INSUFFICIENCY AND HYPERTENSION AND STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEPTUNE CONCHA THERM HEATER HEATER/HUMIDIFIER BZE TELEFLEX MEDICAL NA 1000787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death